Reva Medical Announces Final 5 Year Results for It’s Fantom II Coronary Scaffold Study

REVA Medical, LLC. (“REVA” or the “Company”), a leader in bioresorbable polymer technologies for vascular applications is pleased to announce exceptional 5 Year clinical results from its FANTOM II Study. The trial evaluated the safety and performance of the Company’s Fantom sirolimus-eluting bioresorbable coronary scaffold in over 240 patients outside the United States.

Dr. Matthias Lutz of the University Medical Center Schleswig-Holstein (Kiel, Germany) presented the fully adjudicated 5-year results from the landmark FANTOM II Trial at the 2022 EuroPCR conference in Paris, France. These results demonstrate the ongoing safety and efficacy of the Fantom Sirolimus-Eluting Bioresorbable scaffold through full degradation and resorption from the body. The Fantom device continues to deliver better clinical outcomes than what has been seen in many permanent metal drug eluting stent trials. The low 5-year Target Lesion Failure (TLF) rate of 5.8% demonstrates a long-term trend of favorable patient outcomes in the trial. This is important because the two essential requirements of cardiac stents- to support the vessel during the healing process and to deliver drugs to prevent restenosis-are temporary needs. Therefore, the long-term complications of permanent stents are avoided.

In addition to the final 5-year results from the FANTOM II Trail, Dr. Lutz also presented the 36-month results from a follow-on study that specifically evaluated the use of multiple Fantom scaffolds in treating longer more complex lesions. This smaller sub-study has continued to confirm the initial and long-term safety and performance of the Fantom coronary bioresorbable scaffold in a more complex real world patient population.

Presentation material delivered at the conference is available at REVA’s website: www.revamedical.com.

About REVA Medical
REVA Medical is a medical device company focused on the development and commercialization of bioresorbable polymer technologies for vascular applications. The Company’s products include MOTIV bioresorbable scaffolds for the treatment of peripheral artery disease, Fantom and Fantom Encore bioresorbable vascular scaffolds for the treatment of coronary artery disease, and TyroSphere embolic beads. REVA is based in San Diego, California.

Fantom, Fantom Encore, and MOTIV have CE Mark only. Fantom, Fantom Encore, and MOTIV are available in select countries in Europe and the Middle East. Fantom, Fantom Encore, MOTIV, and TyroSphere are not available in the U.S. or other countries that do not accept CE Mark. Fantom, Fantom Encore, MOTIV, TyroSphere, and Tyrocore are trademarks of REVA Medical, LLC.